percentage of patients with Eckardt score less than 3 [ Time Frame: at 3rd and 12th month after procedure ] [ Designated as safety issue: No ]

Eckardt score calculated at baseline and after procedure

significant variation of Eckardt score [ Time Frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure ] [ Designated as safety issue: No ]

Eckardt score calculated at baseline and after procedure

significant variation of GIQLI score [ Time Frame: at baseline and at 1st, 3rd, 6th and 12th month after the procedure ] [ Designated as safety issue: No ]

GIQLI score calculated at baseline and after procedure

significant variation of high resolution manometry parameters [ Time Frame: at baseline and at 3rd month after the procedure ] [ Designated as safety issue: No ]

high resolution manometry performed at baseline and at 3rd month after the procedure

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Official Title ICMJE

Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Brief Summary

Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.

An endoscopy is performed under anesthesia with orotracheal intubation. After submucosal saline injection, an entry point in the submucosal space is created at 10 cm above the cardia. The endoscope will create a 12cm long tunnel in the caudal direction by submucosal dissection, stopping at 2cm below cardia. Then the muscular circular internal layer is sectioned on a 9cm length, starting 3 cm below the submucosal entry point. At the end the submucosal entry point is closed with metallic clips. A scanner is performed after the procedure so as to check the esophageal wall integrity. Alimentation is progressively introduced at day 1.